Cleared Traditional

NEISSERIA - KWIK PLUS

K852998 · Micro-Bio-Logics · Microbiology
Jul 1985
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K852998 is an FDA 510(k) clearance for the NEISSERIA - KWIK PLUS, a Kit, Identification, Neisseria Gonorrhoeae (Class I — General Controls, product code JSX), submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on July 23, 1985, 8 days after receiving the submission on July 15, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K852998 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1985
Decision Date July 23, 1985
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSX — Kit, Identification, Neisseria Gonorrhoeae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660